Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruiting
Participants planned
147
Countries
1
Sites
1
Advanced, metastatic or unresectable solid tumors
Key facts
- Sponsor
- BeOne Medicines I GmbH
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 10 Feb 2026 → ongoing
- Decision date (initial)
- 2025-12-11
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Advanced, metastatic or unresectable solid tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10066354 | Adenocarcinoma of the gastroesophageal junction | 10029104 |
| 20.0 | PT | 10033128 | Ovarian cancer | 100000004864 |
| 20.0 | PT | 10075566 | Triple negative breast cancer | 100000004864 |
| 21.0 | PT | 10014733 | Endometrial cancer | 100000004864 |
| 28.0 | PT | 10085481 | Hormone receptor positive HER2 negative breast cancer | 100000004864 |
| 21.1 | PT | 10017758 | Gastric cancer | 100000004864 |
| 20.0 | PT | 10060862 | Prostate cancer | 100000004864 |
| 20.0 | PT | 10005003 | Bladder cancer | 100000004864 |
| 21.1 | PT | 10041067 | Small cell lung cancer | 100000004864 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
BeOne Medicines I GmbH
- Sponsor organisation
- BeOne Medicines I GmbH
- Address
- Aeschengraben 27
- City
- Basel
- Postcode
- 4051
- Country
- Switzerland
Scientific contact point
- Organisation
- BeOne Medicines I GmbH
- Contact name
- BeOne Medical Officer
Public contact point
- Organisation
- BeOne Medicines I GmbH
- Contact name
- BeOne Medical Officer
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 15 | 1 |
| Rest of world
Australia, Korea, Republic of, China, United States
|
— | 132 | — |
Investigational sites
Rigshospitalet
Phase 1 unit, Dept. of Oncology, Blegdamsvej 9, 2100, Copenhagen Oe
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2026-02-10 | 2026-02-10 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-10-30 | Denmark | Acceptable 2025-12-10
|
2025-12-11 |